Dalacin T

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

DALACIN T (Dalacin)

10 mg/ml, emulsion for the skin

Clindamycin
DALACIN T and Dalacin are different trade names for the same drug.

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Dalacin T and what is it used for
• 2. Important information before using Dalacin T
• 3. How to use Dalacin T
• 4. Possible side effects
• 5. How to store Dalacin T
• 6. Contents of the pack and other information

1. What is Dalacin T and what is it used for

Dalacin T emulsion contains the active substance clindamycin in the form of clindamycin phosphate. After application to the skin, clindamycin phosphate is converted into clindamycin, an antibiotic with antibacterial action. Clindamycin acts on bacteria Propionibacteriumacnes, which is one of the causes of common acne.

Indications:

Local treatment of common acne.

2. Important information before using Dalacin T

When not to use Dalacin T:

• If you are allergic to clindamycin or lincomycin (people allergic to one of these substances may also be allergic to the other, so-called cross-reaction), or to any of the other ingredients of this medicine (listed in section 6).
• If you have had colitis during antibiotic treatment.

Warnings and precautions

This medicine is for use on the skin only.
Avoid contact with the eyes, mucous membranes, and broken skin. In case of accidental contact, rinse your eyes, mucous membranes, or broken skin with cold water.
Immediately consult a doctor if you experience diarrhea, especially severe and persistent, or abdominal pain during or after treatment, as these may be symptoms of pseudomembranous colitis (mostly caused by Clostridiumdifficile). This disease, which is a complication of antibiotic therapy, can be life-threatening.
As soon as pseudomembranous colitis is diagnosed, the doctor should advise you to stop using Dalacin T and start appropriate treatment. Do not take anti-peristaltic drugs or other constipating medications.
Tell your doctor if you have had colitis associated with antibiotic therapy, Crohn's disease, or ulcerative colitis in the past.
Dalacin T has an unpleasant taste, so be careful when using it near the mouth.
Dalacin T should be used with caution in patients with a tendency to allergies.
Prolonged use of Dalacin T should be done under close medical supervision.

Children

The safety and efficacy of using this medicine in children under 12 years of age have not been established.

Dalacin T and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Clindamycin inhibits neuromuscular transmission, so use this medicine with caution in patients who are taking muscle relaxants. An antagonistic effect has been observed between clindamycin and erythromycin.
Cross-resistance (resistance to drugs in the same group) has been demonstrated between clindamycin and lincomycin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice.
Pregnancy
There are no studies on the safety of using Dalacin T in pregnant women. This medicine should only be used during pregnancy if your doctor considers it absolutely necessary.
Breastfeeding
Do not use this medicine while breastfeeding.

Driving and using machines

No studies have been conducted on the effects of Dalacin T on the ability to drive and use machines.

Dalacin T contains methyl parahydroxybenzoate (E 218) and cetearyl alcohol

Dalacin T contains methyl parahydroxybenzoate, which may cause allergic reactions, including late-type reactions, and cetearyl alcohol, which may cause local skin reactions, including contact dermatitis.

3. How to use Dalacin T

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
This medicine is for use on the skin only.
Shake before use.

Use in adults and adolescents

Apply a thin layer to the affected areas of the skin twice a day. Wash your hands after using the medicine.

Using more than the recommended dose of Dalacin T

Topically applied medicine may be absorbed in amounts that cause general side effects of clindamycin (see sections 2 and 4).

Missing a dose of Dalacin T

Do not use a double dose to make up for a forgotten dose. If you forget a dose, use the medicine as soon as you remember, unless it is almost time for the next dose.

Stopping use of Dalacin T

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After using Dalacin T, the following side effects may occur:

Very common side effects (occurring in more than 1 in 10 patients):

• skin irritation, hives, excessive dryness of the skin.

Common side effects (occurring in more than 1 in 100 but less than 1 in 10 patients):

• greasiness of the skin.

Frequency not known (cannot be estimated from the available data):

• bacterial folliculitis;
• eye pain;
• abdominal pain, gastrointestinal disorders, pseudomembranous colitis;
• contact dermatitis.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dalacin T

Keep this medicine out of the sight and reach of children.
Store in a cool, dry place. Store in the original package.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Dalacin T contains

• The active substance is clindamycin in the form of clindamycin phosphate. 1 ml of emulsion contains 10 mg of clindamycin.
• The other ingredients are: sodium laurylsarcosinate, glycerol, glycerol monostearate, stearic acid, cetearyl alcohol, isostearyl alcohol, methyl parahydroxybenzoate (E 218), purified water.

What Dalacin T looks like and contents of the pack

Dalacin T is an emulsion.
The pack contains a HDPE bottle with a PP dosing cap, containing 30 ml of emulsion, placed in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Pfizer, S.L.
Avda. de Europa 20-B
Parque Empresarial La Moraleja, 28108 Alcobendas (Madrid), Spain

Manufacturer:

Pfizer Service Company BVBA
Hoge Wei, 10, 1930 Zaventem, Belgium

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish export license number: 765875.7

Parallel import license number: 262/23

Date of leaflet approval: 20.11.2023

[Information about the trademark]